Summary of role:

Reporting to the Head of R&D, and working alongside the R&D Engineer, the jobholder will be the primary source of electronics expertise within the Company. Their primary focus will be to work closely both with external collaborators and with key internal functions including manufacturing, regulatory and commercial with the key objective of enhancing product performance and reliability to meet customer and market needs, and to comply with relevant regulations and optimise for manufacturing.

CANDIDATES MUST HAVE THE RIGHT TO WORK IN THE UK AND NOT REQUIRE SPONSORSHIP.

Key accountabilities:

Work with Manufacturing on scale up, technical aspects of supplier selection, new component, second sourcing and validation, and, visiting subcontractor facilities as necessary.
Provide support for and development of Automated Test Equipment for PCB programming and test plus support for and development of Automated End of Line test equipment for finished devices.
Oversee the diagnosis of product complaints received, identifying the root causes of any problems. Ensure all analysis and resultant actions are systematically captured in CAPA system.
Undertake full verification testing and validation of existing products and new components for product enhancements, and complete follow up actions and any relevant manufacturing documentation.
Manage the end-to-end delivery of product enhancement projects especially relating to electronic circuits, components and systems, including verification, documentation for the company quality system and transfer to manufacturing, implementing any necessary design changes.
Drive the digital electronic design component of current and next generation wearable medical devices including PCB design and layout, microprocessor electronics and related software undertaking testing of hardware and software components as necessary.
Work with other team members to manage all inputs and analyses required for the Company’s technical files, liaising closely with the Company’s regulatory function.
Keep up to date with latest technology trends in electronic engineering, bringing them to bear where appropriate.
Working with the R&D Engineer manage the design and delivery of any new product developments required according to market specification/need.

Dimensions:

Part of internal team of 2 R&D Employees

Personal attributes and core skills:

The job holder must have knowledge of a range of relevant disciplines, especially PCB layout and design, but also physics, digital electronics, electrical engineering and biomedical engineering.
They should have both formal graduate level qualifications and at least 4 years of relevant practical experience.
They will be experienced in product design and development preferably in the context of the medical devices industry and must have a good knowledge of all relevant regulations that pertain to medical devices and an understanding of the clinical setting for devices.
They should have some experience of developing electronics for medical devices preferably with specific experience of generating efficiencies in production cost, space utilisation and power consumption.
They will also have an appreciation of the requirements of factory-based volume manufacturing.
As part of a small team the role is very hands-on and so a preference for practical collaboration and problem solving with colleagues is important.
They will need to have good project planning abilities and be effective at team working with good collaboration and influencing skills.
They will have a systematic approach to problem solving, preferably with experience of using analytical tools (e.g. Root Cause analysis, Ishikawa diagrams)
An eye for detail, thoroughness, and a strong compliance orientation are key requirements.
They will need to have good communication skills, both written and verbal.
They will need to understand the context of their role within the commercial objectives of the company, and have the necessary degree of pragmatism, flexibility and sense of urgency to succeed in a small company environment.

This position is offering a generous salary along with hybrid working 3 days expected onsite along with the opportunity to work with a company who have more than doubled their product output over the last year.